Novo Nordisk A/S : new-generation basal insulin Tresiba® approved in China

Bagsværd, Denmark, 27 September 2017 - Novo Nordisk today announced that the China Food and Drug Administration (CFDA) has approved Tresiba® (insulin degludec) for the treatment of diabetes in China. Tresiba® is a new-generation, once-daily basal insulin with an ultra-long duration of action which allows for flexibility in day-to-day dosing.1

Tresiba® provides significantly lower risk of overall, severe and nocturnal hypoglycaemia (low blood sugar) and comparable reductions of blood sugar levels vs. insulin glargine U100 in people with diabetes.1-4 Studies have also shown that Tresiba® provides significantly lower variability in blood sugar levels compared to insulin glargine U100 and U300.5,6

"There are more adults with diabetes in China than anywhere in the world, and we are delighted that the CFDA's approval brings the availability of Tresiba® in China one step closer," said Mads Krogsgaard Thomsen, executive vice president and chief science officer at Novo Nordisk. "Tresiba® gives physicians and people with diabetes a new treatment option that provides equivalent reductions in blood glucose levels and significantly lower risk of hypoglycaemia."

In the multinational, double-blinded Tresiba® cardiovascular outcomes trial, DEVOTE, reported earlier this year, Tresiba® demonstrated cardiovascular safety and a reduced rate of severe and nocturnal severe hypoglycaemia by 40% and 53% respectively compared to insulin glargine U100 in people with type 2 diabetes.4 In the double-blinded SWITCH trials, Tresiba® demonstrated significantly lower rates of overall, nocturnal and severe hypoglycaemia vs. insulin glargine U100 in the full treatment period in people with type 1 and type 2 diabetes.7,8

China has over 100 million people living with diabetes, and the number is expected to grow to more than 150 million people by 2040.9 Tresiba® is expected to launch in China in Q1 2018.

Corporate Affairs

Novo Allé

2880 Bagsværd Denmark

Telephone:

+45 4444 8888

Internet: www.novonordisk.com CVR no:

24 25 67 90

ZINC ID: HQMMA/TB/0917/0329

Date of Approval: September 2017

Tresiba® (insulin degludec) is a once-daily basal insulin that provides a duration of action beyond 42 hours with a flat and stable glucose-lowering effect.1,6 It provides low variability in blood glucose levels and a lower risk of overall, nocturnal and severe hypoglycaemia vs. insulin glargine U100.1,4 On occasions when administration at the same time of day is not possible, Tresiba® allows for flexibility in day-to-day dosing time with a minimum of eight hours between injections.1 Tresiba® received its first regulatory approval in September 2012 and has since been approved in more than 80 countries globally. It is now commercially available in more than 50 countries.

Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: haemophilia, growth disorders and obesity. Headquartered in Denmark, Novo Nordisk employs approximately 41,400 people in 77 countries and markets its products in more than 165 countries. For more information, visit novonordisk.com, Facebook, Twitter, LinkedIn, YouTube

1. EMA. Tresiba® Summary of Product Characteristics. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-

   _Product_Information/human/002498/WC500138940.pdf. Last accessed: September 2017.

2. Rodbard HW, Cariou B, Zinman B, et al. Comparison of insulin degludec with insulin glargine in insulin-naive subjects with type 2 diabetes: A 2-year randomized, treat-to- target trial. Diabet Med. 2013; 30:1298-1304.

3. Bode BW, Buse JB, Fisher M, et al. Insulin degludec improves glycaemic control with lower nocturnal hypoglycaemia risk than insulin glargine in basal-bolus treatment with mealtime insulin aspart in Type 1 diabetes (BEGIN® Basal-Bolus Type 1): 2-year results of a randomized clinical trial. Diabet Med. 2013; 30:1293-1297.

4. Marso SP, McGuire DK, Zinman B, et al. Efficacy and safety of degludec versus glargine in type 2 diabetes. N Engl J Med. 2017; 377:723-732.

5. Heise T, Norskov M, Nosek L, et al. Insulin degludec: Lower day-to-day and within-day variability in pharmacodynamic response compared with insulin glargine 300 U/mL in type 1 diabetes. Diabetes Obes Metab. 2017; 19:1032-1039.

6. Haahr H, Heise T. A review of the pharmacological properties of insulin degludec and their clinical relevance. Clin Pharmacokinet. 2014; 53:787-800.

7. Wysham C, Bhargava A, Chaykin L, et al. Effect of insulin degludec vs insulin glargine U100 on hypoglycemia in patients with type 2 diabetes: The SWITCH 2 randomized clinical trial. JAMA. 2017; 318:45-56.

8. Lane W, Bailey TS, Gerety G, et al. Effect of insulin degludec vs insulin galrgine U100 on hypoglycemia in patients with type 1 diabetes: The SWITCH 1 randomized clinical trial. JAMA. 2017; 318:33-44.

9. International Diabetes Federation. IDF Diabetes Atlas 7th edition, 2015.